The Department of Pharmaceuticals (DoP) has set aside the National Pharmaceutical Pricing Authority (NPPA)'s controversial order dated 24.6.2016 fixing the ceiling price of “Ecoflac Plus Self Collasible Closed System Infusion Containers”.

Earlier, the NPPA in its order No. S.O. 2210(E) dated 24.6.2016 had fixed the ceiling price of Ecoflac Plus Self Collasible Closed System Infusion Containers under Drugs (Prices Control) Order, 2013 (DPCO 2013).

Aggrieved by the NPPA order, B.Braun Medical (India) Pvt. Ltd had filed a review application with the reviewing authority DoP.

In the review petition, the petitioner stated that further to amendment of DPCO 2013 para 11(3), NPPA notified ceiling prices for glucose 5% injection, sodium chloride 0.9% injection and glucose 5% injection and sodium chloride 0.9% injection vide Order S.O. 1993 (E) dated 3 rd June 2016 based on packing, various packaging and special features mentioned in the Note “E? of the said notification. NPPA issued fresh notification S.O. 2210(E) dated 24th June, 2016 refixing the prices of various IV fluids. Said Notification has clubbed our products Ecoflac Plus Self Collapsible Closed System Containers with other products which are not comparable to those of B. Braun on therapeutic and clinical rationale. The company further submitted that the unique features of Ecoflac Plus Self collapsible Closed System Infusion Containers which are different from other companies cited in the S.O. 2210(E), showing therapeutic superiority of the Ecoflac Plus over the products of such other companies.

In reply, NPPA stated that the authority has verified the special features of the products claimed by different companies those demonstrated before the Special Sitting of Authority on 21.6.2016. Separate ceiling price cannot be given on the basis of each feature separately to every company. Letter has been issued to Baxter regarding the PTR and MAT value of Implementation of 100 Viaflex sodium chloride 0.9% solution. The revision will be made on the basis of reply from Baxter. The ceiling price for 100ml specific pack is fixed by NPPA by deriving from the existing ceiling price under the common principle adopted by Committee of Experts of Pharmacoeconomics duly approved by the Authority. The manufacturers were selling this product as “without price approval”. Hence decision taken by NPPA is correct and in consumer interest.

In the examination, the DoP noted that the NPPA has notified the prices of IV fluids on 3.6.2016 in compliance of Government?s Review Order dated 5.5.2016 vide SO NO.1993(E). Subsequently, NPPA once again, suo-motu, revised the prices of IV fluid vide their SO No. 2210(E), dated 24.6.2016 without any specific and express powers under the DPCO to do so. The provision under Para 18(i) of DPCO 2013 clearly stipulates that the revision of ceiling price shall be undertaken. “as and when the National List of Essential Medicines is revised by the ministry of health and family welfare or five years from the date of fixing the ceiling price under this Order whichever is earlier;”

In this particular case, neither the NLEM has been revised by ministry of health & family welfare during the period from 3.6.2016 to 24.6.2016, nor there is a gap of five years from the date of fixing the ceiling price under NPPA’s Order, dated 3.6.2016 nor is there any express order of the Government under any review petition to re-examine the ceiling price in question fixed vide NPPA order dated 3.6.2016.

The basis of the 2nd suo-motu revision of IV fluids vide NPPA SO No.2210(E), dated 24.6.2016 does not seem to be covered under DPCO 2013. It is also noticed that the impugned suo-motu re-fixation of ceiling prices by NPPA, has been done in its Authority Meeting held on 23rd June, 2016, under modified categories of glass, non-glass and separate ceiling prices for specific manufacturers of non-glass with special features, without any consultation or recommendation of the Expert Committee set up under Para 11 (4) of DPCO. Therefore NPPA's SO No.2210( E) dated 24.06.2016 is liable to be set aside.

After examination, the DoP ordered, “In the light of the foregoing analysis, Impugned Order of the NPPA vide S.O. No.2210(E)dated 24.06.2016 is hereby set aside with immediate effect”.